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Registration Dossier
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EC number: 402-730-9 | CAS number: 54914-85-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation, 1,2-Bis(3-methylphenoxy)ethane does not need to be classified for germ cell mutagenicity
according to CLP, EU GHS (Regulation (EC) No 1272/2008).
- Gene mutation in bacteria: negative in S. typhimurium TA1535, TA 1537, TA 1538, TA98, TA100 (with and without metabolic activation); OECD TG 471; RL 2; GLP
- in vitro cytogenicity / chromosome aberration study in mammalian cells: negative in CHO cells (with and without metabolic activation); EU Method B.10; RL 2; GLP
- Gene mutation in mammalian cells: negative in HPRT test with CHO cells (with and without metabolic activation); OECD TG 476; RL 2; GLP
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 61 ... 5000 μg/plate (with metabolic activation)
61 ... 5000 μg/plate (without metabolic activation)
None of the concentrations in the range between 0.05 and 5000 micrograms/L was toxic, but the test substance precipitated at the highest dose level in th test plates. Therefore, this dose level was chosen as the highest dose level in the mutagenicity test. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- The mutagenic potential of the substance was investigated in an in vitro test acccording to OECD method 471. Result with and without metabolic activation were negative.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 84/449/EEC
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 185.2 μg/ml
Concentration range in the main test (with metabolic activation): 555.6 μg/ml
Concentration range in the main test (with metabolic activation): 1666.8 μg/ml
Concentration range in the main test (with metabolic activation): 5000.4 μg/ml
Concentration range in the main test (without metabolic activation): 185.2 μg/ml
Concentration range in the main test (without metabolic activation): 555.6 μg/ml
Concentration range in the main test (without metabolic activation): 1666.8 μg/ml
Concentration range in the main test (without metabolic activation): 5000.4 μg/ml - Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- None of the concentrations in the range of 6.86-5000 µg/mL was cytotoxic
- Conclusions:
- The genotoxicty of the substance was investigated in a chromosome aberration study according to EU method B.10 using Chinese hamster ovary cells. The test was negative with and without metabolic activation.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- 1984
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 1 ... 100 μg/ml
Concentration range in the main test (without metabolic activation): 1 ... 100 μg/ml - Vehicle / solvent:
- DMSO (the test substance is soluble up to 50 mg)
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 4 hours
Exposure period (without metabolic activation): 4 hours
Expression time: 18 - 20 h
Selection time: 8 days
Fixation time: 20 min - Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 100 µg/mL
- Conclusions:
- In a gene mutation test according to OECD 476 using CHO cells the substance did not cause gene mutations with and without metabolic activation.
Referenceopen allclose all
Mitotic index:
without metabolic activation at 5000 micrograms/mL: MI: 2.8
with metabolic activation at 5000 micrograms/mL: MI: 4.0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the results of the full set of in-vitro genotoxicity tests required by REACH regulation, 1,2-Bis(3-methylphenoxy)ethane does not need to be classified for germ cell mutagenicity
according to CLP, EU GHS (Regulation (EC) No 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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